Actively Recruiting
Olutasidenib With Azacitidine Followed by Olutasidenib Maintenance for the Treatment of IDH1-mutated Acute Myeloid Leukemia in Patients With Prior Treatment With Venetoclax Plus a Hypomethylating Agent
Led by University of California, Davis · Updated on 2026-03-05
28
Participants Needed
1
Research Sites
315 weeks
Total Duration
On this page
Sponsors
U
University of California, Davis
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial studies how well giving olutasidenib with azacitidine, followed by olutasidenib maintenance, works in treating patients with IDH1-mutated acute myeloid leukemia (AML) who have received prior treatment with venetoclax plus a hypomethylating agent (HMA-Ven). Olutasidenib and azacitidine may inhibit the growth of cancer cells by blocking certain enzymes required for cell growth. Maintenance therapy can help prevent or delay cancer from coming back. Olutasidenib with azacitidine followed by olutasidenib maintenance may be effective in treating patients with IDH1-mutated AML who have received prior HMA-Ven.
CONDITIONS
Official Title
Olutasidenib With Azacitidine Followed by Olutasidenib Maintenance for the Treatment of IDH1-mutated Acute Myeloid Leukemia in Patients With Prior Treatment With Venetoclax Plus a Hypomethylating Agent
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Pathologically confirmed AML (excluding acute promyelocytic leukemia with t(15;17))
- Achieved complete response or remission with incomplete count recovery after first-line venetoclax plus hypomethylating agent
- Documented IDH1-R132 mutation at diagnosis or after starting venetoclax plus hypomethylating agent
- Received 4 or fewer cycles of venetoclax plus hypomethylating agent before enrollment
- Discontinued venetoclax at least 1 week before starting study treatment
- Eligible for standard azacitidine treatment
- ECOG performance status of 2 or less (Karnofsky 50% or higher)
- No prior solid organ transplant
- Recovery from prior treatment side effects to grade 1 or baseline except infertility or hair loss
- Creatinine clearance 40 mL/min or higher
- ALT and AST levels 3 times or less the upper limit of normal
- Bilirubin 2 times or less the upper limit of normal unless due to Gilbert's syndrome or controlled autoimmune hemolytic anemia
- Prothrombin time, INR, or aPTT 1.5 times or less the upper limit of normal
- Agree to use effective contraception during the study and for 90 days after last dose
- Signed informed consent form prior to any study procedures
You will not qualify if you...
- Prior treatment with IDH1 inhibitor therapy
- Prior AML treatments other than venetoclax plus hypomethylating agent
- History of other cancers unless disease-free for at least 12 months or approved by investigator
- Symptomatic central nervous system metastases or tumor locations requiring urgent intervention
- Previous allogeneic stem cell transplant for non-AML indications within 100 days, active graft versus host disease, or receiving immunosuppressive therapy for graft versus host disease
- Radiation therapy or major surgery within 2 weeks before study drug dosing
- Unable to swallow oral medications or with gastrointestinal conditions affecting absorption
- Severe heart failure, recent heart attack, uncontrolled hypertension, or arrhythmias
- Baseline corrected QT interval over 480 msec (except with bundle branch block and cardiology clearance)
- Use of medications causing Torsades de Pointes started less than five half-lives before study drug
- Chronic corticosteroid treatment above specified low dose
- Known HIV infection
- Active uncontrolled infections requiring systemic treatment
- Uncontrolled metabolic disorders related to disease
- Pregnant, breastfeeding, or planning pregnancy during study or within 90 days after last dose
- Planning to donate sperm or conceive during study or within 90 days after last dose
- Unable or unwilling to comply with study procedures or protocol
- Medical or psychiatric conditions that impair understanding, consent, compliance, or study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
Research Team
O
OCR Referral Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here